Topical Vitamin B12 in Chronic Plaque Psoriasis

What Was Tested

This registered phase 3 trial tested Cyanocobalamin (Vitamin B12) for psoriasis and psoriatic arthritis.

Design: Multicenter, double-blind, randomized, placebo-controlled trial.

The registry classes the interventions as drug.

More on the Plan

Setting: ambulatory patients in research or referral centers.

Patients: Volunteer sample of 51 patients with chronic plaque psoriasis.

Interventions: All Patients applied vitamin B12 cream twice daily for 8 weeks to one side of the body and placebo to the other.

Main outcome measures: Modified Psoriasis Area and Severity Index (PASI) at weeks 0, 2, 4, 6 and 8.

Who Took Part

48 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Chronic plaque psoriasis.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: incapability of vitamin b12; necessity of systemic therapy; use of other potentially psoriasis modifying drugs.

How the Study Was Run

The set-up was randomized, single-group and double-blind.

Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Neither the psoriasis and psoriatic arthritis participants nor the staff measuring them knew who was on Cyanocobalamin (Vitamin B12), so expectations could not easily colour the readings.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2001-01 with completion listed for 2004-12.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Main outcome measures: Modified Psoriasis Area and Severity Index (PASI) at weeks 0, 2, 4, 6 and 8. Thickness and density of 3 references plaques determined by 20 MHz sonography. Assessment of efficiency and tolerability by patients and investigators.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cyanocobalamin (Vitamin B12) in 48 people with psoriasis and psoriatic arthritis.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, Psoriasis and psoriatic arthritis research.